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- Title
INTRODUCING THE LIFE SCIENCES INNOVATION CASE STUDY PROJECT.
- Authors
Schmitt, Allison A.
- Abstract
This Issue of the Berkeley Technology Law Journal presents the results from an ambitious and broad pilot study of the institutions, funders, patent, and regulatory regimes that shape biomedical innovation. This study relies on a comparative analysis of real-world case study examples of breakthrough inventions in the life sciences ecosystem to facilitate evidence-based policy recommendations for allocation of scarce IP, regulatory, and funding resources grounded in real life sciences inventive pathways. Over the 2022–23 academic year, students enrolled in Berkeley Law’s Life Sciences & Innovation Workshop drafted the five case studies published in this Issue. The case studies range from small-molecule therapeutics (Lyrica, Truvada, and Spravato) to biological products (Yescarta) and platform technologies (next-generation sequencing). In each case study, the author examined the scientific background, development history, and innovation “drivers” and “impediments” that led to successful commercialization of the invention. This Article describes the methodology used to develop each case study and provides key comparative insights on the innovation drivers and impediments most critical to successful commercialization for these examples. Even at this preliminary stage of the project, the case studies highlight the importance of early-stage serendipitous discovery and the key role of the Bayh-Dole Act in facilitating later-stage commercialization efforts—whether through startup companies or large pharmaceutical companies. The case studies also illustrate the incentive structures that IP rights create for manufacturers and the important role of the U.S. regulatory framework in shaping innovation. And several case studies highlight ethical, moral, and political considerations that helped to develop environments conducive to scientific research. Expanding the case study universe in future work will lead to further development of the evidence-based policies and resource allocations offered here—and identification of additional policies to advance life science innovation.
- Subjects
LIFE sciences; TECHNOLOGICAL innovations; FINANCE; BIOLOGICAL products; PHARMACEUTICAL industry
- Publication
Berkeley Technology Law Journal, 2024, Vol 39, p345
- ISSN
1086-3818
- Publication type
Article
- DOI
10.15779/Z384B2X61J